FDA 510(k) clearances — page 1238
clearances on record, most recent first.
Clearances — page 1238
123,701–123,800 of 175,890- K905406 — OSTEONICS HIP REVISION WEDGES
- K905662 — SYSTEMATE GGT (EPOS APPLICATION) #65414
- K903463 — IVT INTRODUCER SHEATH
- K903671 — ATHANS EKG STANDARDIZER
- K903939 — PANDA HELIUM GAS ANALYZER
- K904083 — RUBEOLA IGM ELISA TEST
- K904114 — ANATECH X-RAY GENERATOR
- K904275 — MORSE BALLOON INFLATION DEVICE
- K904602 — MEDTRONIC MODEL 5301B TEST CABLE
- K904884 — ACS URETHAN CORONARY GUIDING CATHETER
- K904941 — MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE
- K905149 — TITAN GEL
- K905486 — IMMUNOWELL TPO (MICROSOME) TEST
- K905566 — KODAK EKTASCAN MULTI-FORMAT IMAGER VARIOUS MODELS
- K901953 — AIROX AXR. 1A
- K902691 — DOPPLER OPTION FOR PLATINUM
- K903128 — STIMTRAC PC, CATALOG NO. 78-8510
- K903552 — ORAL-CATH SUCTION CATHETER
- K904231 — MODEL OSP, SANDHILL AMS
- K904693 — CUSTOMED CARDIOVASCULAR PACK
- K904694 — CUSTOMED ANGIODRAPE PACK FEMORAL
- K904695 — GDC-1501
- K904715 — OXYGEN/AIR TUBING
- K904716 — AERO-GEN NEBULIZER
- K904719 — DISPOSABLE FACE MASK
- K905070 — VISTAR
- K905201 — TPN FLUID TRANSFER SET
- K905667 — LANEX EXAM GLOVES
- K896851 — PGR HIP STEM (ENDOPROSTHESIS) FOR LARGE BONE RESEC
- K903117 — ORION STERILE OR TOWELS
- K903946 — COOL CAST(R)
- K904560 — VALLEYLAB LAPAROSCOPIC HANDSWITCH/ELECTRODES
- K904795 — FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM
- K905271 — PRIDE SPIRIT
- K905299 — ROMFLEX REHABILITATION EQUIPMENT
- K905576 — LINGRAPHICA VISUAL LANGUAGE PROSTHESIS
- K905655 — NONABSORBABLE POLYPROPYLENE SURGICAL MESH
- K905671 — BRODA WHEELCHAIR
- K903300 — RESP-EZ(TM) RESPIRATORY MONITORING BELT
- K903844 — OMNISHUNT SYSTEM FOR VENTRICULAR SHUNTING
- K903961 — MEASLES IGG MICROASSAY
- K904403 — BARD AMBULATORY PCA DRUG DELIVERY SYSTEM
- K904472 — GLASSMAN STONE EXTRACTION SET
- K904545 — FORCE GSU TM SYSTEM AND FORCE GSU TM HANDSET
- K904557 — MICROFLO
- K904586 — PALEX IRRIGATION SET
- K904644 — EUROSUN MODELS - ES-2400, ES-VHO AND ES-16
- K904927 — HENNSON INTERNATIONAL DENTAL CAD/CAM SYSTEM
- K905003 — BIO-GUARD SHAVE PREP TRAY
- K905015 — SURGITEK ERECTEK TM EXTERNAL ERECTION DEVICE
- K905203 — COAGULATION REFERENCE PLASMA, NORMAL
- K905483 — MEMORYMATE MODEL 8270 ITE HEARING AID
- K905684 — ALKALINE PHOSPHATASE
- K896903 — FIRST MEDIC MODEL 510
- K903083 — NEONATAL VENTILATOR CIRCUIT
- K903113 — CGA-112 COPING GOLD ALLOY
- K903376 — ACROMED SACRAL SCREW
- K903580 — MICRO-MISTER
- K904034 — TEMPORARY DENTAL CEMENT
- K904039 — REFLECTANCE SENSOR (RS-10)
- K904336 — NEW COBE SATURATION/HEMATOCRIT MONITOR
- K904674 — CENTRAL VENOUS PRESSURE MANOMETER
- K904680 — THERATEK GROUP EXCHANGE CATHETER
- K904997 — ABUSCREEN ONLINE TM FOR OPIATES
- K905147 — ADULT,STERILE,DISPOS.,NONIVAS.,BLOOD PRESS. CUFFS
- K905197 — THE BRACKET ASSEMBLY WITH A SECURITY SYSTEM
- K905544 — MAGNESIUM REAGENT
- K905592 — AFFINITY FSH TEST SYSTEM
- K905697 — POWERED VENTILATOR, LEVER I/II, BATTLEFIELD USE
- K895965 — DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70
- K902987 — G.E. DXS 350/550/650/650II SINGLE PHASE GENERATORS
- K903039 — A-1101 CAST ABUTMENT
- K903126 — CHOLESTAT(TM) WHOLE BLOOD CHOLESTEROL TEST
- K903965 — STATPAL BLOOD GAS MONITORING SYSTEM
- K904081 — GLUCOMETER QA BLOOD GLUCOSE METER AND GLUCOFILM
- K904082 — CHOLESTECH LIPID MONITORING SYSTEM, GLUCOSE TEST
- K904524 — CAPTIA(R) SYPHILIS M, MODIFICATION
- K904568 — EMIT(R) II CANNABINOID 100 NG ASSAY
- K904569 — EMIT(R) II 9 CANNABINOID NEGATIVE CALIBRA/CONTROLS
- K904570 — EMIT(R) II CANNABINOID 20 NG ASSAY
- K904571 — EMIT(R) II CANNABINOID 50 NG ASSAY
- K904612 — I/A-PHACO SYSTEM (IRR./ASPIR./AND PHACO./SYSTEM)
- K904767 — ACS CHOLESTREROL/TRIGLYCERIDE LIQUID LINEAR CALIBR
- K904814 — GLYC-AFFIN GP
- K905222 — CEDARS-SINAI QUANTITATIVE TI-201 ANALYSIS CTQ 2.0
- K905296 — CHOLESTECH LIPID MONITORING SYSTEM,HDL CHOLESTEROL
- K905389 — CHEM-CHEX LIPID
- K905521 — CEDIA(R) THEOPHYLLINE ASSAY/MODIFICATION
- K905622 — COULTER DIRECT BILLRUBIN REAGENT
- K902993 — SYSTEMS FLOW 2000
- K903224 — EPISENSOR
- K903643 — DEKNATEL MICROFLEX OPHTHALMIC POLYPROPYLENE SUTURE
- K904426 — PANOSOL II UVA-218
- K904427 — PANOSOL II UVB-206
- K904428 — PANOSOL II UAB-228
- K904470 — SUMMIT TECH 19/20 GAUGE OPHTHALMIC FIBERENDOSCOPE
- K904588 — AUTO SUTURE(R) MODIFIED ENDOSCOPIC LIGATING LOOP
- K904906 — SHARPOINT POLYPROPYLENE NONABSORB SURG SUTURES USP
- K905029 — MODEL 2001, MODIFICATION
- K905323 — WILL-CERAM Y AND WILL -CERAM Y-1
Data sourced from openFDA. This site is unofficial and independent of the FDA.